As many as 20 million individuals in the U.S. alone cannot make sufficient saliva for normal function and comfort, a condition called xerostomia. The vast majority of these (about 16 million) have xerostomia as a side-effect of prescription medications, another 4 million due to Sjögren's Syndrome and approximately 300,000 become xerostomic each year secondary to head and neck radiation for cancer. Aside from discomfort and pain, related to chronically dry oral mucosa, xerostomia often leads to tooth caries and Candidiasis due to the lack of salivary functions related to enzymatic activity and buffering. Numerous lubricating and saliva substitute products have generally been ineffective in bringing desired relief. (See, e.g., Furness et al., Interventions for the management of dry mouth: topical therapies, The Cochrane Collaboration and published in The Cochrane Library 2011, Issue 12).
Average whole saliva flow in healthy individuals is about 1.0 L to 1.5 L per day (0.7 to 1.0 ml/min). (Humphrey and Williams, A review of saliva: Normal composition, flow and function, J Prosthet Dent 2001; 85(2):162-9). Xerostomia (dry mouth) due to hyposalivation is commonly defined as stimulated flow of less than or equal to 0.2 ml/minute. (Al-Nawas et al., Quantifying radioxerostomia: Salivary flow rate, examiner's score, and quality of life questionnaire, Strahlenther Onkol 2006; 182(6):336-41). As noted, discomfort and pain are related to chronically dry oral mucosa, while increased disease processes are related to the lack of salivary functions which are chemistry dependent.
Disease Background/Unmet Medical Need:
Dry mouth is a common problem with a range of causes. The symptom may be due to a reduction in the quantity of saliva produced, with a feeling of dry mouth. Radiotherapy or chemotherapy for head and neck cancers, and diseases such as Sjögren's Syndrome, may result in reduced saliva production. Many commonly prescribed medications are associated with a feeling of dry mouth, despite normal saliva production. As well as difficulty in speaking, chewing and swallowing, prolonged dry mouth may result in increased risk of tooth decay and reduced quality of life.
Thus, despite efforts to date, a need remains for artificial salivary gland assemblies, and related methods of use. These and other inefficiencies and opportunities for improvement are addressed and/or overcome by the assemblies, systems and methods of the present disclosure.